Monthly Archives: March 2015

iBio, Inc. (NYSE: IBIO) announced it received notice from the European Patent Office that the opposition period expired for a bio-defense product patent granted to iBio, and no opposition was filed.

The patent, entitled “Yersinia Pestis Antigens, Vaccine Compositions and Related Methods” (European patent EP 2178558), includes claims covering plague antigens fused to a thermostable protein such as the Company’s iBioModulator ” thermostable immunomodulator, as well as vaccine compositions and a method for producing the antigen.

“This is an important extension of our commercial platform,” said Robert Erwin, iBio’s president. “We expect our success with vaccine and therapeutic product candidates for use against serious infectious disease agents with weapon potential, such as plague bacillus, to be of interest to governments and companies engaged in supplying disease countermeasures.”

The Defense Advanced Research Projects Agency (DARPA), the Pentagon’s $2.9 billion technology research arm, plans to invest heavily in “synthetic biology” — a field focused on creating man-made life which is widely seen as a future source of drugs, materials, and biofuels.Foreseeing brain implants, bionic limbs, and more Ebola-like outbreaks, DARPA says that biology “is rich in potential breakthroughs” for the military and national security, according to a report published on Thursday. A decade ago, physics and computer science dominated its efforts. Now more than than $300 million of the agency’s budget goes toward biological projects — a number that is expected to grow.“We think there are very potent opportunities to harness biology as a technology,” said DARPA Director Arati Prabhakar at a briefing last week on the new report.

Forty years ago today, the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, better known as the Biological Weapons Convention (BWC), entered into force. It was the first multilateral treaty to ban an entire category of weapons.

The BWC continues to be an essential element in the international community’s efforts to prohibit and eliminate these weapons, the use of which the treaty declares “would be repugnant to the conscience of mankind.” 173 countries have joined the Convention, a significant accomplishment, but still not enough. Universal membership in the treaty would demonstrate humanity’s consensus that biological weapons are illegitimate and that all states have a responsibility to prevent anyone from obtaining them.

Since the BWC entered into force, the tremendous advances in science and technology that have made it easier to diagnose and treat diseases have also made it easier to develop biological weapons, including by terrorists. The same equipment and technical knowledge used to save lives can also be used to weaponize pathogens. This is not just a theoretical concern. We experienced this horror in 2001 when anthrax was sent in letters to Members of Congress and others, killing six Americans. The threat is continues today, as the technology to develop biological weapons is widespread and disguising such efforts is surprisingly easy.

(Reuters) – Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the U.S. Department of Health and Human Services (HHS). Emergent Bio developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research and Development Authority (BARDA), a part of the HHS. The drug is already being stored in the U.S. Strategic National Stockpile, the

A measles outbreak and a deadly strain of flu that caused the deaths of some children this winter are just two examples of diseases that recently caught U.S. public health officials by surprise.

“The rate and scope and spread of the illnesses were not detected before severe consequences occurred,” said Jeff Runge, former chief medical officer for the Department of Homeland Security, and now director of the National Collaborative for Bio-Preparedness at the University of North Carolina-Chapel Hill. The West African Ebola outbreak was also unexpected, he added.

“These are cautionary tales underscoring the need for better biological intelligence,” he said at an Armed Forces Communications and Electronics Association homeland security conference.

Since the anthrax attacks of 2001, the U.S. government’s intention has been to create a global disease-monitoring system. This proposed network would be similar to weather services that report not only what is occurring now, but offers forecasts and predictions so governments, the public and private sectors can react. This regime would also include plant and animal diseases that pose threats to humans.

“It has been 10 years since we embarked on this, and progress has been quite slow,” Runge added.

President Barack Obama issued a national strategy on biosurveillance in 2012, which included a technology roadmap identifying research-and-development priorities.

The document said a biosurveillance network should provide essential information to decision-makers, said Navy Cmdr. Janka Jones, director of medical programs in the office of the assistant secretary of defense for nuclear, chemical and biological defense.

That information must be put in the hands of doctors, veterinarians, “all the way to a mayor that might be making a decision to stop a metro line from running,” said Jones, who helped co-write the national strategy while serving in the White House.

“We’ve got a lot of capability. We don’t have a lot of money to build new capability. [And] the capability we have is just not leveraged ideally,” she said.

The Blue Ribbon Study Panel on Biodefense concluded that the U.S. is unprepared for a biological or chemical weapons attack and lacks the infrastructure necessary to detect such an attack.

The panel, consisting of Sen. Sheldon Whitehouse (D-R.I.), former Sen. Joe Lieberman, former Homeland Security Secretary Tom Ridge, former Secretary of Health and Human Services Donna Shalala, former Sen. Tom Daschle, former Rep. Jim Greenwood and the Honorable Kenneth Wainstein, concluded the third of four meetings on the subject.

“Our legislative and executive branches are not capable of producing an effective reaction to an eventual biological threat,” Whitehouse said in a press release. “The Blue Ribbon Study Panel is addressing a vital issue that government hasn’t been able to rally behind.”

The third meeting consisted of the warnings and discussions about how to improve surveillance for biological and chemical threats.

DELRAY BEACH, Fla., March 18, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has filed an additional U.S. patent for its Firefly Dx real-time PCR (polymerase chain reaction) pathogen detection system titled, “A Cyclical PCR Device with Reusable Heat Zones.” This brings the Company’s patents and patents pending for Firefly Dx to four, and the Company’s total number of patents and patents pending to 18.

Firefly Dx is designed to provide real-time, accurate diagnostic results using PCR chemistry in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. This new patent application covers a PCR device to provide test results in less than 20 minutes while still using standard laboratory volumes and processes in an automated cartridge.

DELRAY BEACH, Fla., March 12, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has successfully completed its first round of testing of its phase II Firefly Dx prototype handheld real-time PCR (polymerase chain reaction) pathogen detection system, and has delivered positive PCR results within 20 minutes. The Company’s Firefly Dx testing was performed at standard laboratory volumes and achieved equivalent results to laboratory-based PCR instruments, which can take hours to perform the same PCR process.

The Company previously announced it completed its Firefly Dx PCR design, and it has now completed successful testing on its Phase II breadboard Firefly Dx system, with consistent and repeated detection of each positive challenge. With the completion of the PCR chip design with confirmatory results, the Company is now in the next phase of testing to encompass optimization and a broader spectrum of tests.

“Having recently completed our Firefly Dx breadboard prototype, these initial positive results of our new PCR chip, which could fundamentally change the real-time PCR industry, are very encouraging,” stated William J. Caragol, Chairman and CEO of PositiveID. “These test results also validate our approach covered in the PCR chip patent application we just filed. Our Firefly Dx testing and development continues to progress on schedule.”

Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets’ report Polymerase Chain Reaction (PCR) – Products/Tools – A Global Market Watch, 2009-2015. Firefly’s applications include point of need monitoring of pathogenic outbreaks (such as Ebola, influenza, etc.), agricultural screening in both domestic sectors and developing countries, and for the detection of biological agents associated with weapons of mass destruction.

A recent DHS Inspector General report found that the Science and Technology Directorate mismanaged a biodetection project, effectively wasting $23 million. The IG’s findings should be taken with a dose of understanding. Here are three …